CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 192 enrolled
Drug / intervention
RotaTeq™ (V260) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01926015
NCT01926015Phase 4Completed
CompareCT.gov

Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

Merck Sharp & Dohme LLC·interventional·Posted Aug 20, 2013·Updated Nov 14, 2018

In Brief

A Phase 4 clinical trial evaluating RotaTeq™ (V260) and DTP-IPV for Rotavirus Disease. Completed, enrolled 192 participants.

Detailed Summary

The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRotavirus Disease
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 20, 2013
Enrollment StartSep 19, 2013
Primary CompletionJun 6, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.9 years ago

Interventions

RotaTeq™ (V260)biological

Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains

DTP-IPVbiological

Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule